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EMEA/CHMP/ICH/437986/2006. ICH Topic E15. Definitions for genomicbiomarkers, pharmacogenomics, pharmacokinetics, genomic data and sample coding...
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What is ich e15?
ICH E15 is a guidance document developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that outlines the structure and content of clinical trial protocols for the submission of data to regulatory authorities.
Who is required to file ich e15?
Sponsors of clinical trials are required to file ICH E15 when submitting data to regulatory authorities.
How to fill out ich e15?
ICH E15 should be filled out according to the guidelines provided in the document, including providing detailed information on the study design, endpoints, statistical analysis, and safety monitoring.
What is the purpose of ich e15?
The purpose of ICH E15 is to ensure that clinical trial protocols are structured and reported in a consistent and comprehensive manner, allowing for accurate assessment of the data by regulatory authorities.
What information must be reported on ich e15?
ICH E15 requires the reporting of detailed information on the study design, endpoints, statistical analysis, and safety monitoring procedures.
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